Back to resultsA Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family
Primary Purpose
Chronic Obstructive Pulmonary Disease Severe
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Decision Support Intervention
Health Coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease Severe focused on measuring Advance Care Planning, Decision making, End-of-life care
Eligibility Criteria
Inclusion Criteria of patients: are aged 50 years or over have been diagnosed with COPD are cognitively sound (scored > 5 on the validated Abbreviated Mental Test (Hong Kong version) [AMT-HK]) meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition can nominate a family member who would take part in their healthcare decision- making. Inclusion Criteria of patients' family members: are aged 18 years or over, can communicate in Cantonese, have at least one personal contact per week with the patient in the past 6 months and are willing to join the study. Family members will be excluded if they score < 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months. Exclusion Criteria: non-communicable due to a severe hearing impairment, dysphasia or a language barrier; are receiving palliative care services or have already completed ACP or an advance directive.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Decision Support Intervention
Health coaching
Outcomes
Primary Outcome Measures
Decisional conflict at T0
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Decisional conflict at T1
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Decisional conflict at T2
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Secondary Outcome Measures
Self-efficacy for ACP at T0
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Self-efficacy for ACP at T1
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Self-efficacy for ACP at T2
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Readiness for ACP at T0
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Readiness for ACP at T1
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Readiness for ACP at T2
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Family members' engagement in ACP at T0
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
Family members' engagement in ACP at T1
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
Family members' engagement in ACP at T2
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
End-of-life care preferences at T1
End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
End-of-life care preferences at T2
End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
Advance directives at T2
Participants will be asked if they have completed advance directives in the past six months.
Full Information
NCT ID
NCT06008210
First Posted
August 18, 2023
Last Updated
August 25, 2023
Sponsor
Food and Health Bureau, Hong Kong
Collaborators
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT06008210
Brief Title
A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family
Official Title
Effects of a Decision Support Intervention on End-of-life Care Planning in Patients With Advanced Chronic Obstructive Pulmonary Disease and Their Family Members: A Mixed Method Approach
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Food and Health Bureau, Hong Kong
Collaborators
Hospital Authority, Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to support EOL decision-making in patients with advanced COPD and their family members. A parallel two-arm single-blinded randomised controlled trial will be conducted to evaluate the effects of a specific decision support intervention. A total of 226 patients with advanced COPD and their designated family members will be recruited from hospital wards and outpatient clinics.
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive life-limiting condition. However, patients with advanced COPD and their family members generally are unprepared for end-of-life (EOL) situations. The Ottawa Decision Support Framework model is adopted to address the patients' decisional needs for the difficult decisions in EOL care. The participants will be randomly allocated to either the intervention group to receive the decision support intervention or the control group to receive general health coaching. Outcomes will be measured at baseline and 1- and 6-month post-allocation. Subsequently, a descriptive qualitative study will be conducted with a subsample of 30 dyads to explore how the intervention influenced the study outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Severe
Keywords
Advance Care Planning, Decision making, End-of-life care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A parallel two-arm single-blinded randomised controlled trial will be conducted.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
226 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Decision Support Intervention
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Health coaching
Intervention Type
Behavioral
Intervention Name(s)
Decision Support Intervention
Intervention Description
The participants will receive two 60-minute consultation sessions delivered by a trained nurse in four weeks at home. Participant's family members will be encouraged to attend the sessions. In the first session, the nurse will explore the participant's understanding of the current health condition, introduce the concept of advance care planning and discuss their decisional needs for end-of-life care decision-making. In the second session, the nurse will ask the participants to complete a value clarification exercise individually.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching
Intervention Description
The participants will receive two 60-minute health coaching sessions delivered by a trained nurse in four weeks at home. This intervention will focus on lifestyle modification and self-care management unrelated to the tested intervention content or outcomes.
Primary Outcome Measure Information:
Title
Decisional conflict at T0
Description
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Time Frame
Baseline
Title
Decisional conflict at T1
Description
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Time Frame
1-month post allocation
Title
Decisional conflict at T2
Description
Decisional conflict regarding EOL care measured using The SURE test. It includes four items to be rated on a dichotomous format, with 0 (no) or 1 (yes). The total score ranged from 0 to 4, with a higher score means less decisional conflict.
Time Frame
6-month post allocation
Secondary Outcome Measure Information:
Title
Self-efficacy for ACP at T0
Description
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Time Frame
Baseline
Title
Self-efficacy for ACP at T1
Description
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Time Frame
1-month post allocation
Title
Self-efficacy for ACP at T2
Description
Self-efficacy for ACP measured using the 3-item Self-efficacy subscale of the ACP Engagement Survey. Participants will rate their level of self-efficacy regarding three ACP actions - namely, appointing a surrogate and discussing EOL care with a surrogate and with medical doctors - using a five-point Likert scale. A higher score indicates a higher level of self-efficacy.
Time Frame
6-month post allocation
Title
Readiness for ACP at T0
Description
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Time Frame
Baseline
Title
Readiness for ACP at T1
Description
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Time Frame
1-month post allocation
Title
Readiness for ACP at T2
Description
Readiness for completing the aforementioned three ACP actions based on the ACP Engagement Survey. Participants will rate their readiness using a five-point scale, from 1 (never thought about it) to 5 (completed already). The total score ranged from 4 to 20. A higher score indicates a higher level of readiness.
Time Frame
6-month post allocation
Title
Family members' engagement in ACP at T0
Description
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
Time Frame
Baseline
Title
Family members' engagement in ACP at T1
Description
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
Time Frame
1-month post allocation
Title
Family members' engagement in ACP at T2
Description
Family members' engagement in ACP will be measured by using the 17-item ACP Engagement Survey for Surrogate Decision Makers. Participants will rate their level of engagement using a five-point scale, from 1 (least) to 5 (highest). The total score ranged from 17 to 85. A higher score indicates a higher level of engagement.
Time Frame
6-month post allocation
Title
End-of-life care preferences at T1
Description
End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
Time Frame
1-month post allocation
Title
End-of-life care preferences at T2
Description
End-of-life care preferences will be determined using the adapted Life-Support Preferences Questionnaire. Participants will be asked to indicate whether they would accept cardiopulmonary resuscitation, mechanical ventilator and tube feeding if they become seriously ill and mentally incapacitated. There are three options: yes, no and uncertain. In addition, they will be asked to indicate their preferred goal of end-of-life care. The available options are maintain life at all costs, maintain comfort and uncertain. There is no scoring for the responses.
Time Frame
6-month post allocation
Title
Advance directives at T2
Description
Participants will be asked if they have completed advance directives in the past six months.
Time Frame
6-month post allocation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria of patients:
are aged 50 years or over
have been diagnosed with COPD
are cognitively sound (scored > 5 on the validated Abbreviated Mental Test (Hong Kong version) [AMT-HK])
meet at least two of the six specific clinical indicators related to advanced COPD in the Gold Standards Framework (GSF) Proactive Identification Guidance, 6th Edition
can nominate a family member who would take part in their healthcare decision- making.
Inclusion Criteria of patients' family members:
are aged 18 years or over,
can communicate in Cantonese,
have at least one personal contact per week with the patient in the past 6 months and
are willing to join the study. Family members will be excluded if they score < 6 on the AMT-HK or are expecting to leave Hong Kong within the next 6 months.
Exclusion Criteria:
non-communicable due to a severe hearing impairment, dysphasia or a language barrier;
are receiving palliative care services or
have already completed ACP or an advance directive.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Chan, Ph.D.
Phone
39438099
Email
helencyl@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Chan, Ph.D.
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will be shared upon request
Learn more about this trial
A Decision Aid on End-of-life Care for Patients With Advanced COPD and Their Family
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